Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes and moderate renal impairment

Conditions: Diabetes Mellitus, Type 2
MedDRA version: 15.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-002968-24-PL

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 274

Inclusion Criteria

• Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including:
- Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines.
or
- Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) =10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines.
• HbA1c 7–10% (both inclusive).
• Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR of 30-59 mL/min/1.73 m^2 per MDRD formula at the screening visit.
• BMI 20–45 kg/m^2 (both inclusive).
• Male or female, age 18-80 years (both inclusive).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

• Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator.
• Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (= 7 days in total) treatment with rapid- or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator.
• Impaired liver function, defined as ALAT =2.5 times upper normal limit.
• History of chronic pancreatitis or idiopathic acute pancreatitis.
• Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG).
• Heart failure defined as New York Heart Association (NYHA) class IV.
• A systolic blood pressure =180 mmHg or a diastolic blood pressure =100 mmHg.
• Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator.
• Use of immunosuppressive treatment within 90 days prior to screening.
• Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer).
• Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the superiority of liraglutide versus placebo as add-on to existing oral antidiabetic drug (OAD) and/or insulin therapy on glycaemic control after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment;Secondary Objective: • To evaluate and compare the effect on cardiovascular risk factors of liraglutide versus placebo as add-on to existing OAD and/or insulin therapy after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment<br>• To evaluate and compare safety and tolerability of liraglutide versus placebo as add-on to existing OAD and/or insulin therapy after 26 weeks treatment in subjects with type 2 diabetes and moderate renal impairment<br>;Primary end point(s): Change in HbA1c from baseline to Week 26.;Timepoint(s) of evaluation of this end point: From baseline to Week 26

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Selected secondary endpoints<br>After 26 weeks treatment:<br>1. HbA1c <7.0% and no weight gain (yes/no)<br>2. HbA1c <7.0% and no minor or severe hypoglycaemic episodes (yes/no)<br><br>Change from baseline to week 26 in:<br>3. Self-measured plasma glucose (SMPG) 7-point profiles<br> - Mean 7-point profile<br> - Postprandial increments after breakfast, lunch and dinner, respectively<br>4. Body mass index (BMI) <br><br>Selected safety endpoints <br>Change from baseline to Week 26 in:<br>5. Renal function <br> - estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula” <br>;Timepoint(s) of evaluation of this end point: 1. After 26 weeks treatment<br>2. After 26 weeks treatment<br>3. From baseline to week 26 <br>4. From baseline to week 26 <br>5. From baseline to week 26 <br>

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